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COVAX-19 (or SpikoGen) is a recombinant protein-based COVID-19 vaccine developed by South Australian-based biotech company Vaxine, in collaboration with CinnaGen, a private company with operations in the Middle East. It is under clinical trial in collaboration with the Iranian company CinnaGen.[3][4][5]
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | Protein subunit |
| Clinical data | |
| Trade names | Spikogen[1] |
| Routes of administration | Intramuscular |
| Legal status | |
| Legal status |
|
| Identifiers | |
| CAS Number | |
Medical uses
editIt requires two doses 21 days apart given by intramuscular injection.[4]
Pharmacology
editCOVAX-19 is a recombinant protein subunit.[6]
History
editVaxine began work on a COVID-19 vaccine in January 2020. After developing a vaccine adjuvant the company decided to focus on a "recombinant protein-based vaccine". A phase 1 human trial started in June 2020. The phase 1 trial involved 40 participants, 30 of whom received the vaccine. The remaining ten participants received a saline placebo.[7]
Phases 2 and 3 clinical trials of COVAX-19 are being conducted in Iran under a co-operation agreement.[8] Phase 2 clinical trials started in May 2021 and Phase 3 trials commenced in August 2021. In the phase 2 trials, 400 Iranian volunteers were injected with either a placebo or the first dose of the vaccine. If the studies are successful, Cinnagen will produce the vaccine under the name SpikoGen in Iran.[7][9]
Clinical trials
edit| Phase | Registration number | Start | Number of participants | Age of participants | Location | Ref | ||
|---|---|---|---|---|---|---|---|---|
| Total | Vaccine | Placebo | ||||||
| I | NCT04453852 | 30 June 2020 | 40 | 30 | 10 | 18–65 years | Adelaide, Australia | [10][11] |
| II | IRCT20150303021315N23 | 30 May 2021 | 400 | 300 | 100 | 18+ years | Tehran, Iran | [12] |
| NCT04944368 | [13] | |||||||
| III | IRCT20150303021315N24 | 7 August 2021 | 16,876 | 12,657 | 4,219 | 18–50 years | Tehran, Iran | [4] |
| NCT05005559 | [14] | |||||||
Authorisations
editOn 6 October 2021, Iran approved the vaccine for emergency use.[15]
See also
editReferences
edit- ^ Clinical trial number NCT04944368 for "Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)" at ClinicalTrials.gov
- ^ "Patent Landscape Report COVID-19-related vaccines and therapeutics" (PDF).
- ^ ""Spikogen", A Joint Venture Between Vaxine And Cinnagen". Vaxine. Archived from the original on 11 July 2021. Retrieved 28 July 2021.
- ^ a b c "A phase III, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. (Two doses of 25 μg with dosing interval of 21 days)". irct.ir. 2 August 2021. IRCT20150303021315N24. Archived from the original on 3 August 2021. Retrieved 3 August 2021.
- ^ Griffin P (23 June 2021). "What is COVAX-19? Australia's most advanced COVID vaccine candidate". medicine.uq.edu.au. Retrieved 5 August 2021.
- ^ Clinical trial number NCT04453852 for "Monovalent Recombinant COVID19 Vaccine (COVAX19)" at ClinicalTrials.gov
- ^ a b Griffin, Paul (23 June 2021). "What is COVAX-19, the most advanced of Australia's remaining local COVID vaccine candidates?". The Conversation. Retrieved 15 November 2021.
- ^ ""SpikoGen", a joint venture between Vaxine and CinnaGen – Vaxine". Archived from the original on 11 July 2021. Retrieved 28 July 2021.
- ^ "CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine's COVID-19 Vaccine Technology – Vaxine". Archived from the original on 15 November 2021. Retrieved 15 November 2021.
- ^ Vaxine Pty Ltd (5 May 2021). "A Randomised, Controlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Adjuvanted Recombinant Protein SARS-COV-2 Vaccine in Healthy Adult Subjects". Central Adelaide Local Health Network Incorporated.
- ^ "چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen" (in Persian). 26 April 2020. Archived from the original on 9 July 2021. Retrieved 7 September 2021.
- ^ "IRCT | A phase II, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. (Two doses of 25 μg with dosing interval of 21 days)". en.irct.ir. Retrieved 7 September 2021.
- ^ Cinnagen (14 August 2021). "A Phase II, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)". Vaxine Pty Ltd.
- ^ Cinnagen (11 August 2021). "A Phase III, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)". Vaxine Pty Ltd.
- ^ "Iran issues emergency permit for new local Covid-19 vaccine". Mehr News Agency. 6 October 2021. Retrieved 11 October 2021.
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